Gradovir 50 mg Film-Coated Tablets

GRADOVIR contains the active substance dolutegravir (as dolutegravir sodium). GRADOVIR is a type of medicine known as an anti-retroviral and belongs to a group of medicines called integrase inhibitors (INIs). GRADOVIR is used to treat HIV infection in combination with antiretroviral medicines in adults aged 18 years and older. GRADOVIR does not cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. As a result of that, it also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. GRADOVIR is always used in combination with other anti-retroviral medicines (combination therapy).

Do not take GRADOVIR:

• if you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of GRADOVIR (listed in section 6).
• if you are taking another medicine called dofetilide or pilsicainide (to treat heart conditions).
• if you have moderate or severe liver problems.
• If you are pregnant (in your first trimester) or breastfeeding your baby.
• If you are a woman of child-bearing age not using effective contraception. GRADOVIR could seriously harm your unborn child if you fall pregnant while on treatment or if you start taking GRADOVIR in the first few weeks of your pregnancy (see Pregnancy and breastfeeding).

Tell your doctor if you are taking metformin to treat diabetes. You must not take metformin and GRADOVIR together.

Warnings and precautions

Take special care with GRADOVIR: Tell your doctor if:

• You are pregnant or suspect that you might be pregnant, you should immediately tell your doctor. Taking GRADOVIR when conception takes place may cause serious birth defects in your baby. If you want to become pregnant, while on GRADOVIR treatment, consult your healthcare provider before trying to conceive a baby. You might need to be switched to another type of medicine (see Do not take GRADOVIR and Pregnancy and breastfeeding).
• You develop a rash, stop taking GRADOVIR and tell your doctor immediately. Some people taking GRADOVIR have had allergic reactions.
• You get any symptoms of infection or inflammation while you are taking GRADOVIR. People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections (such as tuberculosis) flare up, causing signs and symptoms of inflammation.
• Your body shape changes, because of changes in fat distribution. People taking combination therapy for HIV may find that their body shape changes, and that they have higher blood sugar and blood lipid (fat in the blood) levels.
• You experience joint pain, joint stiffness or difficulty in movement, you should see your doctor immediately.
• You do not see your doctor regularly. Keep in touch with your doctor, and do not stop taking GRADOVIR without your doctor’s advice. You might still develop infections.
• You have regular sexual contact with someone or if there has been transfer of your blood to another person by sharing needles. HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). GRADOVIR will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV, use a condom when you have oral or penetrative sex and do not risk blood transfer (for example, don’t share needles). HIV can still be transmitted despite taking GRADOVIR. GRADOVIR does not cure HIV infection; it reduces the amount of virus in your body.
• You have liver problems or if you have an infection in your liver called hepatitis B or C.
• You are taking any other medicine you need to tell your doctor about it. This includes herbal or traditional medicines and medicines that you are taking that do not need a prescription (see Other medicines and GRADOVIR).

Keep in touch with your doctor, and do not stop taking GRADOVIR without your doctor’s advice. You might still develop infections. For as long as you are taking GRADOVIR your doctor may arrange for blood tests.

Children and adolescents

There is no experience with GRADOVIR in children and adolescents younger than 18 years.

Other medicines and GRADOVIR

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Antidysrhythmics (e.g. dofetilide, pilsicainide): medicine used to treat heart conditions (see Do not take GRADOVIR).
• Antidiabetics (e.g. metformin): medicine used to treat diabetes (see Do not take GRADOVIR).
• Antacids: medicines used to treat indigestion and heartburn. Do not take an antacid during the 2 hours before you take GRADOVIR, or for at least 6 hours after you have taken GRADOVIR.
• Supplements (e.g. calcium supplements, iron supplements, multivitamins): Do not take a calcium or iron supplement during the 2 hours before you have taken GRADOVIR, or for at least 6 hours after you take GRADOVIR.
• Antivirals (e.g. etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir): medicines used to treat HIV infection.
• Antimycobacterials (e.g. rifampicin): medicine used to treat tuberculosis.
• Anticonvulsants (e.g. phenytoin, phenobarbitone, oxcarbazine, carbamazepine): medicines used to treat epilepsy.
• Herbal medicines e.g. St. John’s wort - Hypericum perforatum: a herbal remedy used for depression.
• Antifungals (e.g. ketoconazole, fluconazole, itraconazole): medicines used to treat fungal infections.
• Corticosteroids (e.g. prednisone): medicine used to treat swelling (inflammation).
• Oral contraceptives: medicines used to prevent pregnancy or regulate your menstrual cycle.
• Analgesics (e.g. methadone): medicines used to treat pain.

GRADOVIR with food and drink: GRADOVIR may be taken at any time of the day, with or without food.

Do not share medicines prescribed for you with any other person. Always take GRADOVIR exactly as your doctor has told you. Check with your doctor if you are not sure. The usual dose of GRADOVIR is one 50 mg tablet once a day. Your doctor will decide on the correct dose of GRADOVIR for you. Swallow the tablet with some liquid. GRADOVIR can be taken with or without food.

Your doctor will tell you how long your treatment with GRADOVIR will last. Do not stop treatment unless your doctor advises you to.

If you have the impression that the effect of GRADOVIR is too strong or too weak, tell your doctor or pharmacist.

If you take more GRADOVIR than you should: In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take GRADOVIR: If you have missed a dose of GRADOVIR, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for forgotten individual doses. If you have forgotten to take several doses contact your doctor without delay.

GRADOVIR can have side effects. Not all side effects reported for GRADOVIR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GRADOVIR, please consult your healthcare provider for advice.

If any of the following happens, stop taking GRADOVIR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to GRADOVIR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• an inflammatory condition which may develop as your immune system becomes stronger (immune reconstitution syndrome or ‘IRIS’). Symptoms can include fever, headache, stomach pain, difficulty breathing, changes in the way your heart beats, restlessness and weakness,
• suicidal thoughts or an attempt to take one’s own life (particularly if you have a history of mental illness),
• yellowing of the skin and the whites of the eyes (jaundice), unusually dark urine, loss of appetite, sudden nausea and vomiting, abnormally tired, pain in the stomach area. These may be signs of liver inflammation (hepatitis) or liver failure.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• difficulty in sleeping (insomnia),
• feelings of deep sadness and unworthiness (depression), anxiety,
• headache, dizziness, abnormal dreams,
• nausea, loose stools (diarrhoea), vomiting, passing wind (flatulence), stomach pain,
• itching (pruritus),
• lack of energy (fatigue),
• increase in the level of liver enzymes when your blood is tested.

Less frequent side effects:

• stomach pain, stomach discomfort,
• pain in the joints (arthralgia), pain in the muscles (myalgia).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of GRADOVIR.

Store all medicines out of reach of children. Store at or below 30 °C. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).